The Baver ADVIA IMS Albumin assay is an in vitro diagnostic device intended to measure Albumin in human serum or plasma. Measurements of albumin are used in the diagnosis, monitoring and treatment of a variety of diseases involving the liver and kidney.

The Bayer ADVIA IMS Total Bilirubin assay is an in vitro diagnostic device intended to measure bilirubin in human serum or plasma. Measurements of direct or total bilirubin, organic compounds formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis, monitoring and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder disorders.

The Bayer ADVIA IMS Carbon Dioxide (CO2) assay is an in vitro diagnostic method intended to measure CO2 in human serum. Measurements of CO2 are used as an aid in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

The Bayer ADVIA IMS Digoxin assay is an in vitro diagnostic device intended to measure Digoxin, a cardioactive drug, in human serum. Measurements of Digoxin are used as an aid in the diagnosis of Digoxin overdose and in the monitoring therapeutic levels of Digoxin to ensure appropriate therapy.

The Baver ADVIA IMS HDL Cholesterol assay is an in vitro diagnostic device intended to measure HDL Cholesterol (a lipoprotein) in human serum and plasma. Such measurements are used as an aid in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

The Bayer ADVIA IMS Inorganic Phosphorus assay is an in vitro diagnostic device intended to measure phosphorus in human serum, plasma or urine. Measurements of inorganic phosphorus are used in the diagnosis, monitoring and treatment of a variety of diseases involving the parathyroid gland and kidney, and vitamin D imbalance.

The Bayer ADVIA IMS Ion Selective Electrode assays for Sodium,Potassium,and Chloride are in vitro diagnostic devices intended to measure these analytes in human serum or plasma. Measurements of sodium are used as an aid in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension. Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Measurements of potassium are used as an aid in the diagnosis and treatment of renal tubular disease, hyperaldosteronism, metabolic alkolosis, adrenocortical disease and diabetic ketoacidosis. Measurements of chloride are used as an aid in the diagnosis and treatment of acid-base and water imbalance. It is especially important to measure chloride during the correction of hypokalemic alkalosis and also during severe, prolonged vomiting which lowers serum chloride levels.

Device Description

Not Found

AI/ML Overview

This response describes the acceptance criteria and study details for several in vitro diagnostic methods on the Bayer ADVIA IMS system, based on the provided text. Since the original text combines multiple device summaries, I've organized the information by individual assay.

1. Albumin method for ADVIA® IMS

1. Acceptance Criteria and Reported Device Performance:

Performance Metric	Acceptance Criteria (Implied by Predicate Performance / Clinical Relevance)	Reported Device Performance (ADVIA IMS)
Imprecision	Similar to or better than predicate (Technicon CHEM 1 Albumin)
Level 2.1 g/dL	(No explicit predicate data provided for this level)	Total CV(%): 1.9
Level 3.4 g/dL	(No explicit predicate data provided for this level)	Total CV(%): 1.6
Level 4.9 g/dL	(No explicit predicate data provided for this level)	Total CV(%): 1.5
Correlation	High correlation (r ≥ 0.975 typically) and low Syx compared to predicate.
Serum	-	N=53, Y=1.01X+0.55, Syx=0.13 g/dL, r=0.990
Plasma(y), Serum(x)	-	N=59, Y=0.96X+0.12, Syx=0.06 g/dL, r=0.978
Analytical Range	Comparable to predicate and clinically relevant	Serum/Plasma: 1 to 6 g/dL
Interference	Minimal effect from common interfering substances	U. Bilirubin (25mg/dL): -4.8% @ 4.2 g/dL
		Hemoglobin (1000mg/dL): +5.7% @ 3.5 g/dL
		Lipids (1000mg/dL): -2.9% @ 3.5 g/dL

2. Sample size and data provenance (test set):

Serum Correlation: N=53. Data provenance is not specified (retrospective or prospective, country of origin).
Plasma/Serum Correlation: N=59. Data provenance is not specified.
Imprecision: Not explicitly stated how many samples per level, but standard practice involves running multiple replicates over several days. Data provenance not specified.
Interfering Substances: For each substance, 1 sample was tested at a specific albumin concentration. Data provenance not specified.

3. Number of experts and qualifications (ground truth for test set):
Not applicable. This is an in-vitro diagnostic device for measuring a chemical analyte. The ground truth would be established by the reference method (predicate device or other accepted laboratory method).

4. Adjudication method (test set):
Not applicable.

5. Multi-reader multi-case (MRMC) comparative effectiveness study:
Not applicable. This is an in-vitro diagnostic device without human-in-the-loop performance.

6. Standalone performance (algorithm only without human-in-the-loop):
Yes, the provided data represents the standalone performance of the ADVIA IMS Albumin method directly compared to the predicate device (Technicon CHEM 1 Albumin) and its own performance characteristics.

7. Type of ground truth used:
For correlation, the predicate device (Technicon CHEM 1 Albumin) served as the comparison system, implying its measurements were considered the "ground truth" or reference. For imprecision, the measured values are compared against themselves over multiple runs.

8. Sample size for training set:
Not applicable. For this type of in-vitro diagnostic device, there isn't a "training set" in the machine learning sense. Performance is validated through analytical studies (imprecision, correlation, interference).

9. How ground truth for training set was established:
Not applicable.

2. T.Bilirubin method for ADVIA® IMS

1. Acceptance Criteria and Reported Device Performance:

Performance Metric	Acceptance Criteria (Implied by Predicate Performance / Clinical Relevance)	Reported Device Performance (ADVIA IMS)
Imprecision	Similar to or better than predicate (Technicon CHEM 1 T.Bilirubin)
Level 1.1 mg/dL	Predicate: 9.1% Total CV	Total CV(%): 7.0
Level 4.5/5.0 mg/dL	Predicate: 4.8% Total CV	Total CV(%): 5.1
Level 17.0/20.0 mg/dL	Predicate: 2.6% Total CV	Total CV(%): 2.4
Correlation	High correlation (r ≥ 0.975 typically) and low Syx compared to predicate.
Serum	-	N=58, Y=1.08X-0.11, Syx=0.26 mg/dL, r=0.998
Plasma(y), Serum(x)	-	N=57, Y=1.01X-0.01, Syx=0.02 mg/dL, r=0.994
Analytical Range	Comparable to predicate and clinically relevant	Serum/Plasma: 0 to 45 mg/dL
Interference	Minimal effect from common interfering substances	Hemoglobin (500mg/dL): +1% @ 6.9 mg/dL
		Lipids (500mg/dL): -34% @ 6.7 mg/dL

2. Sample size and data provenance (test set):

Serum Correlation: N=58. Data provenance is not specified (retrospective or prospective, country of origin).
Plasma/Serum Correlation: N=57. Data provenance is not specified.
Imprecision: Not explicitly stated how many samples per level, but standard practice involves running multiple replicates over several days. Data provenance not specified.
Interfering Substances: For each substance, 1 sample was tested at a specific T.Bilirubin concentration. Data provenance not specified.

4. Adjudication method (test set):
Not applicable.

5. Multi-reader multi-case (MRMC) comparative effectiveness study:
Not applicable.

6. Standalone performance (algorithm only without human-in-the-loop):
Yes, the provided data represents the standalone performance of the ADVIA IMS T.Bilirubin method directly compared to the predicate device (Technicon CHEM 1 T.Bilirubin) and its own performance characteristics.

7. Type of ground truth used:
For correlation, the predicate device (Technicon CHEM 1 T.Bilirubin) served as the comparison system, implying its measurements were considered the "ground truth" or reference. For imprecision, the measured values are compared against themselves over multiple runs.

8. Sample size for training set:
Not applicable.

9. How ground truth for training set was established:
Not applicable.

3. CO2 Method for the Bayer ADVIA Integrated Modular System (IMS)

1. Acceptance Criteria and Reported Device Performance:

Performance Metric	Acceptance Criteria (Implied by Predicate Performance / Clinical Relevance)	Reported Device Performance (ADVIA IMS)
Analytical Range	Comparable to predicate and clinically relevant	10 to 40 mEq/L
Precision (Total)	Similar to or better than predicate (Technicon CHEM 1 CO2)
@ 11.98 mEq/L	Predicate: 4.5% @ 14 mEq/L	5.3%
@ 19.10 mEq/L	Predicate: 3.8% @ 22 mEq/L	4.3%
@ 28.39 mEq/L	Predicate: 3.3% @ 28 mEq/L	3.0%
Correlation	High correlation (r ≥ 0.975 typically) and low Syx compared to predicate.	N=106 (53 pairs), Y=0.99X+0.41 mEq/L, r=0.993, Syx=0.999 mEq/L
Interference	Minimal effect from common interfering substances (e.g., < ±10-15%)	Bilirubin (unconjugated 25mg/dL): -2.0% @ 27.84 mEq/L CO2
		Bilirubin (conjugated 25mg/dL): -37% @ 28.83 mEq/L CO2
		Hemoglobin (500mg/dL): -10.0% @ 28.67 mEq/L CO2
		Lipemia (500mg/dL): No effect stated (value is '-' or missing)

2. Sample size and data provenance (test set):

Correlation: N=106 (53 pairs). Data provenance is not specified.
Precision: Not explicitly stated how many samples per level, but standard practice involves running multiple replicates. Data provenance not specified.
Interfering Substances: For each substance, 1 sample was tested at a specific CO2 concentration. Data provenance not specified.

3. Number of experts and qualifications (ground truth for test set):
Not applicable.

4. Adjudication method (test set):
Not applicable.

5. Multi-reader multi-case (MRMC) comparative effectiveness study:
Not applicable.

6. Standalone performance (algorithm only without human-in-the-loop):
Yes, the provided data represents the standalone performance of the ADVIA IMS CO2 method compared to the predicate device (Technicon CHEM 1 Carbon Dioxide, Enzymatic) and its own performance characteristics.

7. Type of ground truth used:
For correlation, the predicate device (Technicon CHEM 1 Carbon Dioxide, Enzymatic) served as the comparison system. For precision, the measured values are compared against themselves over multiple runs.

8. Sample size for training set:
Not applicable.

9. How ground truth for training set was established:
Not applicable.

4. Digoxin Method for ADVIA IMS

1. Acceptance Criteria and Reported Device Performance:

Performance Metric	Acceptance Criteria (Implied by Predicate Performance / Clinical Relevance)	Reported Device Performance (ADVIA IMS)
Imprecision	Similar to or better than predicate (Bayer Immuno 1 Digoxin)
Level 0.82/0.7 ng/mL	Predicate: 8.2% Total CV	Total CV(%): 6.8
Level 1.80/2.2 ng/mL	Predicate: 4.2% Total CV	Total CV(%): -5.1 (likely typo for 5.1)
Level 3.81/3.4 ng/mL	Predicate: 3.6% Total CV	Total CV(%): 4.8
Correlation	High correlation (r ≥ 0.975 typically) and low Syx compared to predicate.	N=63, Y=0.93X - 0.11, Syx=0.17 ng/mL, R=0.98
Analytical Range	Clinically relevant range	0.1-5.0 ng/mL
Minimum Detectable Concentration	-	0.1 ng/mL
Interference	Minimal effect from common interfering substances	Bilirubin (25mg/dL): 3.9% @ 2 ng/mL
		Bilirubin (unconjugated 25mg/dL): -3.9% @ 2 ng/mL
		Hemoglobin (500mg/dL): -0.3% @ 2 ng/mL
		Lipids (500mg/dL): -11.7% @ 2 ng/mL

2. Sample size and data provenance (test set):

Correlation: N=63. Data provenance is not specified.
Imprecision: Not explicitly stated how many samples per level, but standard practice involves running multiple replicates. Data provenance not specified.
Interfering Substances: For each substance, 1 sample was tested at a specific Digoxin concentration. Data provenance not specified.

3. Number of experts and qualifications (ground truth for test set):
Not applicable.

4. Adjudication method (test set):
Not applicable.

5. Multi-reader multi-case (MRMC) comparative effectiveness study:
Not applicable.

6. Standalone performance (algorithm only without human-in-the-loop):
Yes, the provided data represents the standalone performance of the ADVIA IMS Digoxin method compared to the predicate device (Bayer Immuno 1 Digoxin) and its own performance characteristics.

7. Type of ground truth used:
For correlation, the predicate device (Bayer Immuno 1 Digoxin) served as the comparison system. For imprecision, the measured values are compared against themselves over multiple runs.

8. Sample size for training set:
Not applicable.

9. How ground truth for training set was established:
Not applicable.

5. HDL cholesterol Method for the ADVIA IMS Systems

1. Acceptance Criteria and Reported Device Performance:

Performance Metric	Acceptance Criteria (Implied by Predicate Performance / Clinical Relevance)	Reported Device Performance (ADVIA IMS)
Analytical Range	Clinically relevant range, comparable to predicate	0 to 250 mg/dL
Precision (Total)	Similar to or better than predicate (Bayer Technicon Chem 1 HDL cholesterol)
Level 1 (Mean 18 mg/dL)	Predicate: 8.5% @ 20 mg/dL	% CV: 3.2
Level 2 (Mean 42 mg/dL)	Predicate: 6.7% @ 46 mg/dL	% CV: 2.6
Level 3 (Mean 121 mg/dL)	Predicate: 4.8% @ 58 mg/dL	% CV: 2.8
Correlation	High correlation (r ≥ 0.975 typically) and low Syx compared to predicate.	N=107 (54 samples in duplicate), Y=0.997X+1.95, r=0.987, Sy.x=3.58
Sample Range	-	19 to 123 mg/dL
Plasma Qualification	High correlation to serum measurements	N=90 (47 samples in duplicate), Y=0.995X+0.12, r=0.996, Sy.x=1.3
Interference	Minimal effect from common interfering substances	Hemoglobin (250mg/dL): -19% @ 47.2 mg/dL
		Bilirubin (conjugated 6.25mg/dL): -27% @ 45.2 mg/dL
		Bilirubin (unconjugated 25mg/dL): -2% @ 43.1 mg/dL
		Lipemia (1000mg/dL): +1% @ 44.3 mg/dL

2. Sample size and data provenance (test set):

Correlation: N=107 (54 samples in duplicate). Data provenance is not specified.
Plasma Qualification: N=90 (47 samples in duplicate). Data provenance is not specified.
Precision: Not explicitly stated how many samples per level, but standard practice involves running multiple replicates. Data provenance not specified.
Interfering Substances: For each substance, 1 sample was tested at a specific HDL cholesterol concentration. Data provenance not specified.

3. Number of experts and qualifications (ground truth for test set):
Not applicable.

4. Adjudication method (test set):
Not applicable.

5. Multi-reader multi-case (MRMC) comparative effectiveness study:
Not applicable.

6. Standalone performance (algorithm only without human-in-the-loop):
Yes, the provided data represents the standalone performance of the ADVIA IMS HDL cholesterol method compared to the predicate device (Bayer Technicon Chem 1 HDL cholesterol) and its own performance characteristics.

7. Type of ground truth used:
For correlation, the predicate device (Bayer Technicon Chem 1 HDL cholesterol method) served as the comparison system. For imprecision, the measured values are compared against themselves over multiple runs. For plasma qualification, serum measurements by the ADVIA IMS were used as the comparison.

8. Sample size for training set:
Not applicable.

9. How ground truth for training set was established:
Not applicable.

6. Inorganic Phosphorus method for ADVIA® IMS

1. Acceptance Criteria and Reported Device Performance:

Performance Metric	Acceptance Criteria (Implied by Predicate Performance / Clinical Relevance)	Reported Device Performance (ADVIA IMS)
Imprecision (SERUM)	Similar to or better than predicate (Technicon CHEM 1 Inorganic Phosphorus)
Level 2.5/3.1 mg/dL	Predicate: 3.4% Total CV	Total CV(%): 1.7
Level 5.0/6.6 mg/dL	Predicate: 2.7% Total CV	Total CV(%): 2.1
Level 8.8/7.7 mg/dL	Predicate: 2.8% Total CV	Total CV(%): 2.7
Imprecision (URINE)	Similar to or better than predicate (Technicon CHEM 1 Inorganic Phosphorus)
Level 24.8/37 mg/dL	Predicate: 2.6% Total CV	Total CV(%): 1.9
Level 69.8/55 mg/dL	Predicate: 2.7% Total CV	Total CV(%): 2.2
Level 96.3 mg/dL	(No explicit predicate data provided for this level)	Total CV(%): 1.9
Correlation	High correlation (r ≥ 0.975 typically) and low Syx compared to predicate.
Serum	-	N=50, Y=0.94X+0.15, Syx=0.15 mg/dL, r=0.997
Plasma(y), Serum(x)	-	N=58, Y=0.96X-0.17, Syx=0.12 mg/dL, r=0.977
Urine	-	N=48, Y=1.01X+0.15, Syx=1.17 mg/dL, r=0.999
Analytical Range	Clinically relevant range	Serum/Plasma: 0 to 15 mg/dL, Urine: 0 to 100 mg/dL
Interference	Minimal effect from common interfering substances	Bilirubin (20mg/dL): +2.2% @ 3.7 mg/dL
		Hemoglobin (500mg/dL): +19.4% @ 3.6 mg/dL
		Lipids (500mg/dL): +21.6% @ 3.8 mg/dL
		Acetaminophen (50mg/dL): -3.8% @ 8.0 mg/dL
		Ascorbic Acid (200mg/dL): +1.3% @ 18.4 mg/dL
		Salicylate (500mg/dL): +5.0% @ 18.4 mg/dL

2. Sample size and data provenance (test set):

Serum Correlation: N=50. Data provenance is not specified.
Plasma/Serum Correlation: N=58. Data provenance is not specified.
Urine Correlation: N=48. Data provenance is not specified.
Imprecision: Not explicitly stated how many samples per level, but standard practice involves running multiple replicates. Data provenance not specified.
Interfering Substances: For each substance, 1 sample was tested at a specific Inorganic Phosphorus concentration. Data provenance not specified.

3. Number of experts and qualifications (ground truth for test set):
Not applicable.

4. Adjudication method (test set):
Not applicable.

5. Multi-reader multi-case (MRMC) comparative effectiveness study:
Not applicable.

6. Standalone performance (algorithm only without human-in-the-loop):
Yes, the provided data represents the standalone performance of the ADVIA IMS Inorganic Phosphorus method compared to the predicate device (Technicon CHEM 1 Inorganic Phosphorus) and its own performance characteristics.

7. Type of ground truth used:
For correlation, the predicate device (Technicon CHEM 1 Inorganic Phosphorus) served as the comparison system. For imprecision, the measured values are compared against themselves over multiple runs.

8. Sample size for training set:
Not applicable.

9. How ground truth for training set was established:
Not applicable.

7. Sodium, Potassium, and Chloride ISE methods for ADVIA® IMS

1. Acceptance Criteria and Reported Device Performance:

Performance Metric	Acceptance Criteria (Implied by Predicate Performance / Clinical Relevance)	Reported Device Performance (ADVIA IMS)
Imprecision	Clinically acceptable variability
Sodium (113 mmol/L)	-	Total CV(%): 1.0
Sodium (139 mmol/L)	-	Total CV(%): 1.0
Potassium (3.4 mmol/L)	-	Total CV(%): 1.3
Potassium (5.9 mmol/L)	-	Total CV(%): 1.2
Chloride (93 mmol/L)	-	Total CV(%): 1.2
Chloride (113 mmol/L)	-	Total CV(%): 1.2
Correlation (Serum)	High correlation (r ≥ 0.975 typically) and low Syx compared to predicate.
Sodium	-	N=53, Y=0.94xFlame+7.08, Syx=1.68, R=0.957
Potassium	-	N=54, Y=1.03xFlame-0.15, Syx=0.17, R=0.990
Chloride	-	N=51, Y=0.84xChloridometer+16.0, Syx=1.1, R=0.986
Plasma/Serum Comparison	Minimal difference, clinically acceptable
Sodium Mean Difference	0.0 mmol/L, 0.0% Difference
Potassium Mean Difference	0.21 mmol/L, 5.6% Difference
Chloride Mean Difference	0.0 mmol/L, 0.0% Difference
Analytical Range	Clinically relevant range	Sodium: 40-205 mmol/L, Potassium: 1.5-15 mmol/L, Chloride: 50-200 mmol/L
Interference	Minimal effect from common interfering substances	Sodium: No significant effect from bromide, ammonium, iodide.
		Potassium: Hemolysis should be avoided.
		Chloride: Sodium Salicylate (30 mg/dL): < 2.0 mmol/L elevation. Bromide/iodide salts falsely elevate results.

2. Sample size and data provenance (test set):

Sodium Correlation: N=53. Data provenance is not specified.
Potassium Correlation: N=54. Data provenance is not specified.
Chloride Correlation: N=51. Data provenance is not specified.
Imprecision: Not explicitly stated how many samples per level, but standard practice involves running multiple replicates. Data provenance not specified.
Plasma/Serum Comparison: Not explicitly stated if a specific N was used for this comparison, but "Mean Serum Level" and "Mean Plasma Level" suggest multiple samples. Data provenance not specified.
Interfering Substances: Specific sample sizes for interference tests are not provided; general statements are made. Data provenance not specified.

3. Number of experts and qualifications (ground truth for test set):
Not applicable.

4. Adjudication method (test set):
Not applicable.

5. Multi-reader multi-case (MRMC) comparative effectiveness study:
Not applicable.

6. Standalone performance (algorithm only without human-in-the-loop):
Yes, the provided data represents the standalone performance of the ADVIA IMS Sodium, Potassium, and Chloride methods compared to predicate devices (IL Flame for Na/K, Chloridometer for Cl) and their own performance characteristics.

7. Type of ground truth used:
For correlation, predicate devices (IL Flame and Chloridometer) served as the comparison systems. For imprecision, the measured values are compared against themselves over multiple runs. For plasma/serum comparison, serum values by the ADVIA IMS were used as the comparison.

8. Sample size for training set:
Not applicable.

9. How ground truth for training set was established:
Not applicable.

Summary

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Albumin method for ADVIA® IMS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K992396

1. Intended Use

This in vitro diagnostic method is intended to measure albumin in human serum or plasma on the Baver ADVIA IMS system. Measurements of albumin are used in the diagnosis, monitoring and treatment of a variety of diseases involving the liver and kidneys.

2. Predicate Device

Product Name	Reagent Part #	Calibrator Part #
Technicon CHEM 1 Albumin	T01-1458-53	T03-1291-62

3. Device / Method

Product Name	Reagent Part #	Calibrator Part #
ADVIA IM Albumin	B41-3717-26	T03-1291-62

A. Imprecision(SERUM)

ADVIA IMS
Level (g/dL)	Total CV(%)
2.1	1.9
3.4	1.6
4.9	1.5

Correlation (Y=ADVLA IMS. X=comparison system) 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

Specimen type	Comparison System (X)	N	Regression Equation	Syx (g/dL)	r	Sample Range (g/dL)
Serum	CHEM 1+	53	Y=1.01X+0.55	0.13	0.990	1.4 - 5.3
Plasma(y), Serum(x)	ADVIA IMS	59	Y=0.96X+0.12	0.06	0.978	3.9 - 5.2

Interfering Substances

InterferingSubstance	Interfering Sub.Conc. (mg/dL)	Albumin Conc.(g/dL)	Effect(% change)
U. Bilirubin	25	4.2	-4.8
Hemoglobin	1000	3.5	+5.7
Lipids (Triglycerides)	1000	3.5	-2.9

Analytical Range

Scrum/Plasma: 1 10 6 g/dL

7/16/99

Gabriel J. Murray, Jr.

Manager Reg Affairs.

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS T.Bilirubin method for ADVIA® IMS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.

The assigned 510(k) number is:

1. Intended Use

This in vitro method is intended to quantitatively measure total bilirubin in human serum and plasma on the Bayer ADVIA IMS systems. Measurements of total bilirubin are used in the diagnosis and treatment of liver, bemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder disorders.

2. Predicate Device

Product Name	would be and the country of the country of the country of the country of the country of the country of the country of the country of the country of the country of the country Reagent Part # Calibrator Part # for and and the program and and the many of the many of the many of the many of the many of the may be the may be the may be the may be the may be the may be the may be the b
Technicon CHEM 1 T.Bilirubin T01-1522-53 T03-1291-62

3. Device / Method

Product Name		Reagent Part # Calibrator Part #
www.rangestion.com/production/compress/from the managements of the comments of the comments of the comments of the comments of the comments of the comments of the comments ofADVIA IMS T.Bilirubin	B41-3723-46 T03-1291-62	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Imprecision(SERUM)

ADVIA IMS	CHEM 1
Level(mg/dL)	TotalCV(%)	Level(mg/dL)	TotalCV(%)
1.1	7.0	1.1	9.1
4.5	5.1	5.0	4.8
17.0	2.4	20.0	2.6

Correlation (Y=ADVIA IMS, X=comparison system)

Specimen type	ComparisonSystem (X)	N	Regression Equation	Syx(mg/dL)	r	Sample Range(mg/dL)
Serum	CHEM 1+	58	Y=1.08X-0.11	0.26	0.998	0.2 - 26.1
Plasma(y), Serum(x)	ADVIA IMS	57	Y=1.01X-0.01	0.02	0.994	0.16 - 0.92

Interfering Substances

InterferingSubstance	Interfering Sub.Conc. (mg/dL)	T.BilirubinConc. (mg/dL)	Effect(% change)
Hemoglobin	500	6.9	+1
Lipids (Triglycerides)	500	6.7	-34

Gabriel J. Murray Jr.
Manager Reg. Affairs

Analytical Range

Serum/Plasma: 0 to 45 mg/dL

{2}------------------------------------------------

SUMMARY OF SAFETY AND EFFECTIVENESS

CO2 Method for the Bayer ADVIA Integrated Modular System (IMS)

Listed below is a comparison of the performance between the Bayer ADVIA IMS CO2 method and a similar device that was granted clearance of substantial equivalence (Technicon CHEM 1 Carbon Dioxide, Enzymatic). The information used in the Summary of Safety and Effectiveness was extracted from the Bayer ADVIA IMS CO2 method sheet and the CHEM 1 CO2 (Enzymztic) method sheet.

INTENDED USE

This in-vitro diagnostic method is intended to measure carbon dioxide (CO2) in human serum. Measurement of CO, is used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

METHOD		ADVIA IMS	CHEM 1
Part No.	Reagents	B41-3726-43	T01-3253-53
	Calibrators/CO2 diluent	T03-1291-62/T23-1291-52	T01-1291-62/T23-1291-52
Analytical Range		10 to 40 mEq/L	10 to 40 mEq/L
Precision (Total)		5.3% @ 11.98 mEq/L4.3% @ 19.10 mEq/L3.0% @ 28.39 mEq/L	4.5% @ 14 mEq/L3.8% @ 22 mEq/L3.3% @ 28 mEq/L
Correlation		Y=0.99X+0.41 mEq/LWhereY=ADVIA IMSX=CHEM 1N=106 (53 pairs)	7/16/99Gabriel J. Mno

r=0.993

Sy.x=0.999 mEq/L

Interfering Substances

Bilirubin (unconjugated) 25 mg/dL Bilirubin (conjugated) 25 mg/dL Hemoglobin (hemolysate) 500 mg/dL Lipemia (Triglycerides) 500 mg/dL

-2.0% effect change @ 27.84 mEq/L CO2 -37% effect change @ 28.83 mEq/L CO2 -10.0% effect change @ 28.67 mEq/L CO2

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Digoxin Method for ADVIA IMS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.

The assigned 510(k) number is: (leave blank)

1. Intended Use

This in vitro method is intended to quantitatively measure digoxin in human serum on the Bayer ADVIA IMS systems. Measurements of digoxin are used to aid in attaining optimum therapy in patients treated with the drug.

Predicate Device 2.

Product Name	Reagent Part #	Calibrator Part #
Bayer Immuno 1 Digoxin	T01-2875-51	T01-2864-01

Device / Method 3.

Name
----------------------------------------------------------------------AMC Tunxoxobilithe call a the collection of the consideration of the are of	A 40 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 1	11

A. Imprecision

ADVIA IMS		Immuno 1
Level(ng/mL)	TotalCV (%)	Level(ng/mL)	TotalCV (%)
0.82	6.8	0.7	8.2
1.80	-5.1	2.2	4.2
3.81	4.8	3.4	3.6

B. Correlation (Y=ADVIA IMS, X=Comparison system)

Specimen type	Comparison System (X)	N	Regression Equation	Syx (ng/mL)	R	Sample Range (ng/mL)
Serum	Immuno 1	63	$Y=0.93X - 0.11$	0.17	0.98	0.15-3.90

7/14/99 Gabriel J. Murray Jr. - Manager Reg. Affairs

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C. Interfering Substances
InterferingSubstance	Interfering Sub.Conc. (mg/dL)	Digoxin Conc.(ng/mL)	Effect(% change)
Bilirubin	25	2	3.9
Bilirubin(unconjugated)	25	2	-3.9
Hemoglobin	500	2	-0.3
Lipids(Triglycerides)	500	2	-11.7

2011

. ..........

. . . . . . . . . . . . . . . .

. . . . .

: · ·

Analytical Range: 0.1-5.0 ng/mL Minimum Detectable Concentration: 0.1 ng/mL

Date 7/16/99

Bayer Corporation, Business Group Diagnostics Tarrytown, NY. Gabriel J. M. Gabriel J. Muraca, Jr. Manager Regulatory Affairs

914-524-3494 (fax 914-524-2500)

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SUMMARY OF SAFETY AND EFFECTIVENESS

HDL cholesterol Method for the ADVIA IMS Systems

Listed below is a comparison of the performance of the Bayer ADVIA HDL cholesterol method and a similar device that was granted clearance of substantial equivalence (Bayer Technicon Chem 1 HDL cholesterol method). The information was extracted from the Baver ADVIA IMS HDL cholesterol method sheet.

INTENDED USE

The Bayer ADVIA IMS HDL cholesterol assay is an in-vitro diagnostic device intended to measure HDL cholesterol in human serum and plasma. Such measurements are used in the diagnosis, monitoring and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This diagnostic method is not intended for use on any other diagnostic system.

SERUM

HDL CHOLESTEROLMETHOD:	ADVIA IMS	CHEM 1
Part Number:	Cholesterol ReagentB41-3727-46HDL precipitating reagentB21-3733-01Calibrators T03-1291-62	cholesterol reagentT01-2869-01HDL Precipitating reagentT01-1897-56Calibrators T03-1291-62
Analytical Range:	0 to 250 mg/dL	10 to 100 mg/dL
Precision (Total):	Mean (mg/dL)	% CV
Level 1	18	3.2
Level 2	42	2.6
Level 3	121	2.8
	mean (mg/dL)	% CV
	20	8.5
	46	6.7
	58	4.8

Correlation to existing system
Regression Equation: y = 0.997x + 1.95
where:	y = ADVIA IMS
	x = Chem 1
	n = 107 (54 samples in duplicate)
	r = 0.987
	Sy.x = 3.58
	range = 19 to 123 mg/dL

7/16/94 Gabriel J. Muraca Jr. - Muraca By. Affairs.

{6}------------------------------------------------

Plasma Qualification
Regression Equation: y=0.995X +0.12
where:	y	= plasma
	x	= serum
	n	= 90 (47 samples in duplicate)
	r	= 0.996
	Sy.x	= 1.3
	range	= 18 to 71 mg/dL

Interference

	Interfering SubstanceConcentration	HDLcholesterolConcentration	Effect% Change
Hemoglobin	250 mg/dL	47.2 mg/dL	-19
Bilirubin (conjugated)	6.25 mg/dL	45.2 mg/dL	-27
Bilirubin (unconjugated)	25 mg/dL	43.1 mg/dL	-2
Lipemia (Triglycerides)	1000 mg/dL	44.3 mg/dL	+1

Gabriel J. Munaco Jr.

Andrews and

Gabriel J. Muraca, Jr. Manager Regulatory Affairs. .................................................................................................................................................. Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097

7/6/99
Date

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Inorganic Phosphorus method for ADVIA® IMS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.

The assigned 510(k) number is: _

1. Intended Use

This in vitro diagnostic method is intended to measure Inorganic Phosphorus in luman serum, plasma or urine on the Bayer ADVIA IMS system. . Measurements of inorganic phosphorus are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

2. Predicate Device

Product Name	Reagent Part #	Calibrator Part #
Technicon CHEM 1® InorganicPhosphorus	T01-1609-53	T03-1291-62

3. Device / Method

Product Name	Reagent Part #	Calibrator Part #
ADVIA IMS InorganicPhosphorus	B41-3734-46	T03-1291-62

A. Imprecision(SERUM)

ADVIA IMS
Level(mg/dL)	Total CV(%)	L(m
2.5	1.7
5.0	2.1
8.8	2.7

CHEM 1
Level(mg/dL)	TotalCV(%)
3.1	3.4
6.6	2.7
7.7	2.8

B. Imprecision(URINE)

ADVIA IMS
Level(mg/dL)	TotalCV(%)
24.8	1.9
69.8	2.2
96.3	1.9

CHEM 1
Level(mg/dL)	TotalCV(%)
37	2.6
55	2.7

Correlation (Y=ADVIA IMS, X=comparison system)

Specimen type	Comparison System (X)	N	Regression Equation	Syx (mg/dL)	r	Sample Range (mg/dL)
Serum	CHEM 1+	50	Y = 0.94X + 0.15	0.15	0.997	1.3 - 10.0 mg/dL
Plasma(y), Serum(x)	ADVIA IMS	58	Y=0.96X-0.17	0.12	0.977	1.9-4.4 mg/dL
Urine	CHEM 1	48	Y = 1.01X + 0.15	1.17	0.999	4.5 - 99.9 mg/dL

Gabriel J. Menaca Jr. - Manager Reg. Affairs.
7/16/99

{8}------------------------------------------------

Interfering Substances

InterferingSubstance	Interfering Sub.Conc. (mg/dL)	InorganicPhosphorusConc. (mg/dL)	Effect(% change)
Bilirubin	20	3.7	+2.2
Hemoglobin	500	3.6	+19.4
Lipids (Triglycerides)	500	3.8	+21.6
Acetaminophen	50	8.0	-3.8
Ascorbic Acid	200	18.4	+1.3
Salicylate	500	18.4	+5.0

Analytical Range Serum/Plasma: Urine:

0 to 15 mg/dL 0 to 100 ing/dL

: : :

: 上一篇:

Gabriel J. Munoz Jr.
7/16/99

{9}------------------------------------------------

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Sodium,Potassium,and Chloride ISE methods for ADVIA® IMS I.

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.

The assigned 510(k) number is:

1. Intended Use

This in vitro diagnostic method to measure Sodium (Na), Potassium (K) and Chloride (CI) in human serum, plasma on the Bayer ADVIA IMS system

2. Device / Method

Product Name	Reagent Part #	Calibrator Part #
ADVIA IMS Sodium, Potassium,Chloride	B48-4054-54	T21-4055-01 (Hi)T21-4056-01 (Lo)

Imprecision

ANALYTE	Level (mmol/L)	Total CV(%)
Sodium	113	1.0
	139	1.0
Potassium	3.4	1.3
	5.9	1.2
Chloride	93	1.2
	113	1.2

Correlation (Y=ADVIA IMS, X=comparison system)

ANALYTE (Serum)	Comparison System (X)	N	Regression Equation	Syx (mmol/L)	R	Sample Range (mmol/L)
Sodium	IL Flame	53	$0.94 x Flame + 7.08 mmol/L$	1.68	0.957	120.0-147.1
Potassium	IL Flame	54	$1.03 x Flame - 0.15 mmol/L$	0.17	0.990	2.55-8.72
Chloride	Chloridometer	51	$0.84 x Chloridometer + 16.0 mmol/L$	1.1	0.986	83.6-115.5

Plasma/Serum Comparison

	Sodium	Potassium	Chloride
Mean Serum Level	137.2	3.97	105.2
Mean Plasma Level	137.2	3.76	105.2
Mean Difference	0.0	0.21	0.0
% Difference	0.0	5.6	0.0

Gabriel J. Muraca Jr.

G. J. Muraca Jr.

Manager RA Bayer Corporation

7/6/99

Date

{10}------------------------------------------------

ADVIA IMS ISE Na, K and Cl Report

Interfering Substances

Sodium: No significant effect on serum has been demonstrated from bromide, ammonium and iodide.

Potassium: Since the concentration of potassium inside erythrocytes is much greater than that in extracellular fluid, hemolysis should be avoided, and the serum/plasma should be separated from the cells as soon as possible after collection.

Chloride: Sodium Salicylate at a level of 2.2 mmol/L (30 mg/dL) will elevate the chloride result by less than 2.0 mmol/L. The presence of bromide or iodide salts will falsely elevate chloride results.

Analytical Range Serum or Plasma: Sodium 40 to 205 mmol/L Potassium 1.5 to 15 mmol/L 50 to 200 mmol/L Chloride

Gabriel J. Munoz, Jr.
7/16/99

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Image /page/11/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 1 5 1999

Mr. Gabriel J. Muraca, Jr. Manager. Regulatory Affairs Baver Corporation Business Group Diagnostics 511 Benedict Avenue Tarrytown, New York 10591-5097

K992399 Re:

Trade Name: 9 Additional IMS Assays for the Bayer ADVIA® IMS™ System Regulatory Class: II Product Code: CIX, CIG, CHS, KXT, CHH, CEO JGS, CEM, CGZ Dated: July 16, 1999 Received: July 19, 1999

Dear Mr. Muraca:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{12}------------------------------------------------

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{13}------------------------------------------------

510(k) Number (if known):

Device Name: Bayer ADVIA® Integrated Modular System (IMS)

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use(Optional Format 1-2-96)
------------------------------------------	----	--------------------------------------------------

	(Division Sign-Off) Division of Clinical L 510(k) Number K992399
--	-----------------------------------------------------------------------------------------------------------------------------------------------------------------------

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Page 2 of 2

510(k) Number (if known):

Device Name: Bayer ADVIA® Integrated Modular System IMS

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) .

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.1035 Albumin test system.

(a)
Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.(b)
Classification. Class II.